| HPLC测定复方新斯的明眼用凝胶中马来酸氯苯那敏的含量和有关物质 |
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| 引用本文： | 夏苗芬,李士敏,王华,朱亚尔. HPLC测定复方新斯的明眼用凝胶中马来酸氯苯那敏的含量和有关物质[J]. 中国现代应用药学, 2009, 26(6): 491-493 |
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| 作者姓名： | 夏苗芬 李士敏 王华 朱亚尔 |
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| 作者单位： | 1.浙江医药高等专科学校，浙江 宁波 315100；2.浙江大学分析测试中心，杭州 310029；3.浙江大学药物制剂研究所，杭州 310002 |
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| 摘 要： | 目的建立马来酸氯苯那敏及有关物质的含量测定方法。方法采用固相萃取-高效液相色谱法,EclipseXDB-C18色谱柱（4.6mm×150mm,5μm）。流动相：甲醇-醋酸三乙胺溶液（45∶55）。检测波长：261nm。结果线性范围为1.02～16.32μg·mL^-1,r=0.9999。低、中、高3个浓度的平均回收率为（103.05±1.24）%,（100.87±1.45）%,（99.63±1.03）%。结论本方法简便快速、专属性好、重复性好、易操作。
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| 关 键 词： | 马来酸氯苯那敏 眼用凝胶 有关物质 固相萃取-高效液相色谱法 |
| 收稿时间： | 1900-01-01 |
Determination of Chlorphenamine Maleate and Its Related Substances in Compound Neostigmine Ophthalmic Gel by HPLC |
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| XIA Miaofen,LI Shimin,WANG Hu,ZHU Yaer. Determination of Chlorphenamine Maleate and Its Related Substances in Compound Neostigmine Ophthalmic Gel by HPLC[J]. The Chinese Journal of Modern Applied Pharmacy, 2009, 26(6): 491-493 |
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| Authors: | XIA Miaofen LI Shimin WANG Hu ZHU Yaer |
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| Affiliation: | XIA Miaofen, LI Shimin , WANG Hua, ZHU Yaer (1.Zhejiang Pharmaceutical College, Ningbo 315100, China; 2. Center of Analysis and Measurement, Zhejiang University, Hangzhou 310029, China; 3.Institute of Pharmaceutical Preparation, Zhejiang University, Hangzhou 310002, China) |
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| Abstract: | OBJECTIVE To establish an SPE-HPLC method for determining the content and related substances of chlorphenamine maleate. METHODS An eclipse XBD-C18 column （4.6 mm× 150 mm, 5 μm） was used, and the mobile phase was methanol-acetate triethylamine solution（45 ： 55）. The detective wavelength was 261 nm. RESULTS An excellent linearity （r=0.999 9） was obtained over the range of 1.02-16.32 μg·mL^-1, the recovery of low, medium and high concentration level was （103.05 ±1.24）%, （100.87±1.45）%, （99.63±1.03）%. CONCLUSION This method is sensitive, specific, reproducible and easy to process. |
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| Keywords: | chlorphenamine maleate ophthalmic gel related substances SPE-HPLC |
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